SIST EN 303 203-1 V1.1.1:2014

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.RYElectromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range - Part 1: Technical characteristics and test methods35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technology33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunicationsICS:Ta slovenski standard je istoveten z:EN 303 203-1 Version 1.1.1SIST EN 303 203-1 V1.1.1:2014en01-december-2014SIST EN 303 203-1 V1.1.1:2014SLOVENSKI

ETSI EN 303 203-1 V1.1.1 (2014-11) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs)

operating in the 2 483,5 MHz to 2 500 MHz range; Part 1: Technical characteristics and test methods

Reference DEN/ERM-TG30-304 Keywords health, network, radio, SRD, system, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE

Siret N° 348 623 562 00017 - NAF 742 C Association à but non lucratif enregistrée à la Sous-Préfecture de Grasse (06) N° 7803/88

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ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 3 Contents Intellectual Property Rights ................................................................................................................................ 6 Foreword ............................................................................................................................................................. 6 Modal verbs terminology .................................................................................................................................... 6 Introduction ........................................................................................................................................................ 7 1 Scope ........................................................................................................................................................ 8 2 References ................................................................................................................................................ 8 2.1 Normative references ......................................................................................................................................... 8 2.2 Informative references ........................................................................................................................................ 8 3 Definitions, symbols and abbreviations ................................................................................................... 9 3.1 Definitions .......................................................................................................................................................... 9 3.2 Symbols ............................................................................................................................................................ 11 3.3 Abbreviations ................................................................................................................................................... 11 4 Technical requirements and specifications ............................................................................................. 12 4.1 General requirements ....................................................................................................................................... 12 4.1.1 Transmitter requirements ............................................................................................................................ 12 4.1.2 Receiver requirements ................................................................................................................................ 12 4.2 Presentation of equipment for testing purposes ................................................................................................ 12 4.2.1 Choice of model for testing ........................................................................................................................ 12 4.2.2 Spurious emission testing for composite equipment ................................................................................... 12 4.2.3 Testing of equipment with alternative power levels ................................................................................... 13 4.2.4 Presentation of equipment that does not have an external RF connector (integral antenna equipment) ..... 13 4.2.4.1 Equipment with an internal permanent or temporary antenna connector .............................................. 13 4.2.4.2 Equipment with a temporary antenna connector ................................................................................... 13 4.3 Mechanical and electrical design ...................................................................................................................... 13 4.3.1 General ........................................................................................................................................................ 13 4.3.2 Controls ...................................................................................................................................................... 13 4.3.3 Transmitter shut-off facility ........................................................................................................................ 13 4.4 Declarations by the Applicant .......................................................................................................................... 13 4.5 Auxiliary test equipment .................................................................................................................................. 14 4.6 Interpretation of the measurement results ........................................................................................................ 14 5 Test conditions, power sources and ambient temperatures .................................................................... 14 5.1 Normal and extreme test conditions ................................................................................................................. 14 5.2 Test power source ............................................................................................................................................. 14 5.2.1 External test power source .......................................................................................................................... 14 5.2.2 Internal test power source ........................................................................................................................... 14 5.3 Normal test conditions ...................................................................................................................................... 15 5.3.1 Normal temperature and humidity .............................................................................................................. 15 5.3.2 Normal test power source ........................................................................................................................... 15 5.3.2.1 Mains voltage ........................................................................................................................................ 15 5.3.2.2 Other power sources .............................................................................................................................. 15 5.4 Extreme test conditions .................................................................................................................................... 15 5.4.1 Extreme temperatures ................................................................................................................................. 15 5.4.1.1 Procedure for tests at extreme temperatures .......................................................................................... 15 5.4.1.1.1 Procedure for equipment designed for continuous operation .......................................................... 16 5.4.1.1.2 Procedure for equipment designed for intermittent operation ......................................................... 16 5.4.1.2 Extreme temperature ranges .................................................................................................................. 16 5.4.2 Extreme test source voltages ....................................................................................................................... 17 5.4.2.1 Mains voltage ........................................................................................................................................ 17 5.4.2.2 Other power sources .............................................................................................................................. 17 6 General conditions .................................................................................................................................. 17 6.1 Normal test signals and test modulation ........................................................................................................... 17 SIST EN 303 203-1 V1.1.1:2014

ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 4 6.1.1 Normal modulation test signals for data ..................................................................................................... 17 6.2 Antennas ........................................................................................................................................................... 17 6.3 Test fixture ....................................................................................................................................................... 17 6.4 Test sites and general arrangements for radiated measurements ...................................................................... 18 6.5 Modes of operation of the transmitter .............................................................................................................. 18 6.6 Measuring receiver ........................................................................................................................................... 18 7 Measurement uncertainty ....................................................................................................................... 19 8 Methods of measurement and limits for transmitter parameters ............................................................ 20 8.1 Frequency error ................................................................................................................................................ 20 8.1.1 Definition .................................................................................................................................................... 20 8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode ............ 20 8.1.1.2 Method of measurement for systems with a modulated output frequency ............................................ 21 8.1.2 Limits .......................................................................................................................................................... 21 8.2 Emission bandwidth measurement ................................................................................................................... 21 8.2.1 Definition .................................................................................................................................................... 21 8.2.1.1 Method of measurement ........................................................................................................................ 21 8.2.2 Limits .......................................................................................................................................................... 22 8.3 Effective isotropic radiated power of the fundamental emission ...................................................................... 22 8.3.1 Definition .................................................................................................................................................... 22 8.3.1.1 Methods of measurement ...................................................................................................................... 22 8.3.2 Limits .......................................................................................................................................................... 23 8.4 Spurious emissions ........................................................................................................................................... 23 8.4.1 Definition .................................................................................................................................................... 23 8.4.1.1 Method of measuring the effective radiated power of spurious emissions............................................ 23 8.4.2 Limits .......................................................................................................................................................... 25 8.5 Out-of-band emissions ..................................................................................................................................... 25 8.5.1 Definition .................................................................................................................................................... 25 8.5.2 Methods of measurement ............................................................................................................................ 25 8.5.3 Limits .......................................................................................................................................................... 27 8.6 Frequency stability under low voltage conditions ............................................................................................ 27 8.6.1 Definition .................................................................................................................................................... 27 8.6.1.1 Method of measurement ........................................................................................................................ 27 8.6.2 Limits .......................................................................................................................................................... 27 8.7 MBANS with restricted duty cycle .................................................................................................................. 27 8.7.1 Definitions .................................................................................................................................................. 27 8.7.2 Declaration of Duty Cycle .......................................................................................................................... 28 8.7.3 Limit for duty cycle and maximum number of transmissions .................................................................... 28 9 Methods of measurement and limits for receiver parameters ................................................................. 28 9.1 Spurious radiation............................................................................................................................................. 28 9.1.1 Definition .................................................................................................................................................... 28 9.1.1.1 Method of measuring the effective radiated power of spurious radiations............................................ 28 9.1.2 Limits .......................................................................................................................................................... 29 10 Requirements and Measuring Methods for Monitoring Systems ........................................................... 30 10.1 Purpose ............................................................................................................................................................. 30 10.2 General Remarks on the Measurement Configuration ..................................................................................... 30 10.3 Adaptive Frequency Agility ............................................................................................................................. 30 10.4 LBT threshold power level ............................................................................................................................... 32 10.4.1 Measurement method using frequency administration commands ............................................................. 32 10.4.2 Results based on above test method ............................................................................................................ 32 10.4.3 Limit ........................................................................................................................................................... 32 10.5 Monitoring system bandwidth .......................................................................................................................... 32 10.6 Minimum channel monitoring period ............................................................................................................... 32 10.6.1 Measurement method using frequency administration commands ............................................................. 33 10.6.2 Results based on above test method ............................................................................................................ 33 10.6.3 Limit ........................................................................................................................................................... 33 10.7 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh .............. 33 10.7.1 Accessing an unoccupied channel............................................................................................................... 33 10.7.2 Results accessing an unoccupied channel ................................................................................................... 34 10.7.3 Accessing the Least Interfered Channel...................................................................................................... 34 SIST EN 303 203-1 V1.1.1:2014

ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 5 10.7.4 Results accessing the LIC ........................................................................................................................... 34 10.7.5 Limits .......................................................................................................................................................... 34 Annex A (normative): Radiated measurements ................................................................................ 35 A.1 Test sites and arrangements for radiated measurements ........................................................................ 35 A.1.1 Outdoor test site ............................................................................................................................................... 35 A.1.2 Indoor test site .................................................................................................................................................. 35 A.1.3 Shielded anechoic test site ................................................................................................................................ 36 A.2 Antennas ................................................................................................................................................. 38 A.2.1 Test antenna ...................................................................................................................................................... 38 A.2.2 Substitution antenna ......................................................................................................................................... 38 A.3 Test practice and auxiliary test equipment ............................................................................................. 39 A.3.1 Measuring distance ........................................................................................................................................... 39 A.3.2 Auxiliary cables ................................................................................................................................................ 39 Annex B (informative): Change History .............................................................................................. 40 Annex C (informative): Bibliography ................................................................................................... 41 History .............................................................................................................................................................. 42

ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 6 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (http://ipr.etsi.org). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Foreword This European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document is part 1 of a multi-part deliverable covering Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range, as described in the systems reference document for the equipment, TR 101 557 [i.1], and as identified below: Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".

National transposition dates Date of adoption of this EN: 30 October 2014 Date of latest announcement of this EN (doa): 31 January 2015 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

31 July 2015 Date of withdrawal of any conflicting National Standard (dow): 31 July 2015

Modal verbs terminology In the present document "shall", "shall not", "should", "should not", "may", "may not", "need", "need not", "will", "will not", "can" and "cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). "must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation. SIST EN 303 203-1 V1.1.1:2014

ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 7 Introduction The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to cover all radio and telecommunications terminal equipment within the scope of the R&TTE Directive [i.3]. The modular structure is shown in EG 201 399 [i.4]. The present document describes the technical characteristics and test and performance requirements for Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz frequency range.

Medical Body Area Networks are short-range low-power wireless networks, consisting of a plurality of body-worn sensor devices and/or actuator devices and a hub device placed on/around the human body. The on-body sensor devices are responsible for measuring key patient-specific information, such as the temperature, pulse, blood glucose level, electrocardiogram, blood pressure level and respiratory function readings. The hub device acts as a central controller to maintain the connections with all devices associated with its MBANS and is responsible for device association/de-association and channel selection. The hub device also typically receives the data collected from the various sensor devices on the body and may, depending on applications, process the data locally and/or further forward it to a remote central station (e.g. remote nursing station) via an appropriate wired/wireless link for centralized processing, display and storage.

Usually, MBANS devices are highly resource-constrained in terms of battery capacity, MCU capability and memory size. Therefore, simple and low-power MBANS solutions are preferred from the application point of view. Currently, most of mature low-power low-cost short-range radio solutions have spectrum efficiency around or less than 1 bps/Hz and it is expected that MBANS solutions will have similar spectrum efficiency. Also to prolong battery life, MBANS devices are expected to transmit with a limited duty cycle. The MBANS devices' duty cycle is not more than 10 % for in-hospital applications and not more than 2 % for in-home applications.

In addition to the technical specifications, the present document provides measurement methods for MBANS equipment which should support operation in healthcare facility mode or home mode, or both modes. These measurement methods are to be implemented throughout the process of manufacturing and putting onto the market. And, if the MBANS equipment is required to be checked for the purpose of market surveillance, it should be tested also in accordance with the methods of measurement specified in the present document. The present document is structured as follows: • Clauses 1 through 3 provide a general description of the types of equipment covered by the present document and the definitions of terms and symbols and abbreviations used. • Clause 4 provides details of presentation of equipment for testing. • Clauses 5 and 6 specify the test and general conditions for testing of the equipment. • Clause 7 defines measurement uncertainties of the test system and gives the maximum measurement uncertainty values which should not be exceeded. • Clause 8 specifies the measurement of transmitter parameters, related to spectrum utilization, and which are required to be measured, including frequency error, emission bandwidth, e.i.r.p. of the emission, spurious and out-of-band emissions, and frequency stability.

• Clause 9 specifies measurement methods and limits for receiver parameters. • Clause 10 provides the requirements and measuring methods for monitoring systems, primarily designed to minimize the possibility of disturbance between MBANS equipment and other users of the 2 483,5 MHz to 2 500 MHz frequency range. • Annex A (normative) gives the specifications concerning radiated measurements. • Annex B (informative) provides the change history. • Annex C (informative) provides bibliography. SIST EN 303 203-1 V1.1.1:2014

ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 8 1 Scope The present document covers the minimum characteristics of Medical Body Area Network System (MBANS), including the spectrum monitoring and access requirements, considered necessary in order to make the best use of the available spectrum within the 2 483,5 MHz to2 500 MHz frequency range and to avoid harmful interference between MBANS and other users of this band. It does not necessarily include all the characteristics which may be required by a user, nor does it necessarily represent the optimum performance achievable.

The types of devices that can belong to MBANSs are on-body and off-body medical sensors, patient monitoring devices and medical actuators covered by the Medical De